Clonazepam

What is Clonazepam?

• Clonazepam (Klonopin), is a benzodiazepine used primarily as a anticonvulsant in the adjunctive management of epilepsy.
• It belongs to the class of drugs known as benzodiazepines, which function by enhancing the effects of the neurotransmitter GABA, which inhibits neuronal activity.

Clonazepam

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Clonazepam 200

What are the uses of this medicine?

Clonazepam (Klonopin), is a prescription medicine used alone or with other medicines:

• in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures.
• In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam tablets, USP may be useful.
• to treat panic disorder with or without fear of open spaces (agoraphobia) in adults.

How does this medicine work?

• The precise mechanism by which clonazepam exerts its antiseizure and antipanic effects is unknown, although it is believed to be related to its ability to enhance the activity of gamma aminobutyric acid (GABA), the major inhibitory neurotransmitter in the central nervous system.
• The ability of clonazepam (kloe naz' e pam) and other benzodiazepines to enhance GABA-mediated inhibition of synaptic transmission underlies their anticonvulsant activity.
• This is accomplished by binding to the GABA A receptor, which increases the receptor's affinity for GABA and strengthens its inhibitory effect.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to benzodiazepines
• have significant liver disease
• have an eye disease called acute narrow angle glaucoma

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• amiodarone (Cordarone, Nexterone, Pacerone)
• certain antibiotics such as clarithromycin (Biaxin, in Prevpac), erythromycin (Erythrocin, E-mycin, others), and troleandomycin (TAO) (not available in the US)
• antidepressants
• certain antifungal medications such as itraconazole (Onmel. Sporanox) and ketoconazole (Nizoral)
• antihistamines
• certain calcium channel blockers such as diltiazem (Cardizem, Tiazac, others) and verapamil (Calan, Covera, Verelan, in Tarka)
• cimetidine (Tagamet)
• HIV protease inhibitors including indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir, in Kaletra)
• medications for anxiety, colds or allergies, or mental illness
• other medications for seizures such as carbamazepine (Epitol, Tegretol, Teril), phenobarbital, phenytoin (Dilantin, Phenytek), or valproic acid (Depakene)
• muscle relaxants
• nefazodone
• rifampin (Rifadin, Rimactane)
• sedatives
• certain selective serotonin reuptake inhibitors (SSRIs) such as fluvoxamine (Luvox)
• other sleeping pills
• tranquilizers

• Tell your doctor what herbal products you are taking, especially St. John's wort.

Is this medicine FDA approved?

• In 1997, the FDA of the United States approved clonazepam for the treatment of epilepsy. Currently, over 20 million prescriptions for clonazepam are filled annually.

How should this medicine be used?

Recommended dosage: For Seizure Disorders:

In Adults:

• The initial dose for adults with seizure disorders should not exceed 1.5 mg/day divided into three doses.
• Dosage may be increased in increments of 0.5 to 1 mg every 3 days until seizures are adequately controlled or until side effects preclude any further increase.
• Maintenance dosage must be individualized for each patient depending upon response.
• Maximum recommended daily dose is 20 mg.

In Pediatric Patients:

• In order to minimize drowsiness, the initial dose for infants and children (up to 10 years of age or 30 kg of body weight) should be between 0.01 and 0.03 mg/kg/day but not to exceed 0.05 mg/kg/day given in two or three divided doses.
• Dosage should be increased by no more than 0.25 to 0.5 mg every third day until a daily maintenance dose of 0.1 to 0.2 mg/kg of body weight has been reached.

For Panic Disorder:

In Adults:

• The initial dose for adults with panic disorder is 0.25 mg bid.
• An increase to the target dose for most patients of 1 mg/day may be made after 3 days.
• Treatment should be discontinued gradually, with a decrease of 0.125 mg bid every 3 days, until the drug is completely withdrawn.

In Pediatric Patients:

• There is no clinical trial experience with clonazepam tablets in panic disorder patients under 18 years of age

Administration:

• Take clonazepam tablets exactly as your healthcare provider tells you. If you take clonazepam tablets for seizures, your healthcare provider may change the dose until you are taking the right amount of medicine to control your symptoms.
• Clonazepam is available as a tablet.
• Do not stop taking clonazepam tablets without first talking to your healthcare provider. Stopping clonazepam tablets suddenly can cause serious problems.
• Clonazepam tablets should be taken with water and swallowed whole.
• If you take too many clonazepam tablets, call your healthcare provider or local Poison Control Center right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Clonazepam tablets, USP, for oral administration, contain 0.5 mg, 1 mg or 2 mg clonazepam.

This medicine is available in fallowing brand namesː

• Klonopin

What side effects can this medication cause?

The most common side effects of this medicine include:

• drowsiness
• problems with walking and coordination
• dizziness
• depression
• fatigue
• problems with memory

Less common, but serious side effects may include:

• respiratory depression
• sleepy or dizzy and can slow your thinking and motor skills
• suicidal thoughts or actions
• abuse and dependence
• status epilepticus

What special precautions should I follow?

• Clonazepam tablets can slow your thinking and motor skills. Do not drive, operate heavy machinery, or do other dangerous activities until you know how clonazepam tablets affects you.
• Do not drink alcohol or take other medicines that may make you sleepy or dizzy while taking clonazepam tablets until you talk to your healthcare provider. When taken with alcohol or medicines that cause sleepiness or dizziness, clonazepam tablets may make your sleepiness or dizziness much worse.
• Concomitant use of benzodiazepines, including clonazepam, and opioids may result in profound sedation, respiratory depression, coma, and death. Advise both patients and caregivers about the risks of respiratory depression and sedation when clonazepam is used with opioids.
• Antiepileptic drugs (AEDs), including clonazepam, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Behaviors of concern should be reported immediately to healthcare providers.
• Withdrawal symptoms of the barbiturate type have occurred after the discontinuation of benzodiazepines. Therefore, when discontinuing clonazepam, gradual withdrawal is essential. While clonazepam is being gradually withdrawn, the simultaneous substitution of another anticonvulsant may be indicated.
• When used in patients in whom several different types of seizure disorders coexist, clonazepam may increase the incidence or precipitate the onset of generalized tonic-clonic seizures (grand mal). The concomitant use of valproic acid and clonazepam may produce absence status.
• Periodic blood counts and liver function tests are advisable during long-term therapy with clonazepam.
• Paradoxical reactions, such as agitation, irritability, aggression, anxiety, anger, nightmares, hallucinations, and psychoses are known to occur when using benzodiazepines.
• Metabolites of clonazepam are excreted by the kidneys; to avoid their excess accumulation, caution should be exercised in the administration of the drug to patients with impaired renal function.
• Clonazepam may produce an increase in salivation. This should be considered before giving the drug to patients who have difficulty handling secretions.
• Clonazepam may have a porphyrogenic effect and should be used with care in patients with porphyria.
• Clonazepam therapy poses a low risk of liver damage. It is not associated with serum aminotransferase elevations, and clinically apparent liver injury caused by clonazepam use is extremely uncommon, if it occurs at all.
• Clonazepam can pass into breast milk. You and your healthcare provider should decide how you will feed your baby while you take clonazepam tablets.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• somnolence, confusion, coma and diminished reflexes.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Treatment includes monitoring of respiration, pulse and blood pressure, general supportive measures and immediate gastric lavage.
• Intravenous fluids should be administered and an adequate airway maintained.
• Hypotension may be combated by the use of levarterenol or metaraminol.
• Dialysis is of no known value.
• Flumazenil, a specific benzodiazepine-receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines.
• Patients treated with flumazenil should be monitored for resedation, respiratory depression and other residual benzodiazepine effects for an appropriate period after treatment.
• The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose.
• Flumazenil is not indicated in patients with epilepsy who have been treated with benzodiazepines. Antagonism of the benzodiazepine effect in such patients may provoke seizures.

Can this medicine be used in pregnancy?

• It is not known if clonazepam tablets can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking clonazepam tablets. You and your healthcare provider will decide if you should take clonazepam tablets while you are pregnant.
• Studies in pregnant animals have shown harmful effects of benzodiazepine medications (including the active ingredient in clonazepam tablets) on the developing fetus.
• Children born to mothers receiving benzodiazepine medications (including clonazepam tablets) late in pregnancy may be at some risk of experiencing breathing problems, feeding problems, hypothermia, and withdrawal symptoms.
• If you become pregnant while taking clonazepam tablets, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can register by calling 1-888-233-2334.

Can this medicine be used in children?

• It is not known if clonazepam tablets are safe or effective in treating panic disorder in children younger than 18 years old.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• clonazepam

Inactive ingredients:

• 0.5 mg tablets contain corn starch, lactose anhydrous, magnesium stearate, microcrystalline cellulose, D&C yellow No. 10 aluminum lake
• 1 mg tablets contain corn starch, lactose anhydrous, magnesium stearate, microcrystalline cellulose, FD&C Blue No. 1 aluminum lake
• 2 mg tablets contain corn starch, lactose anhydrous, magnesium stearate, microcrystalline cellulose

Who manufactures and distributes this medicine?

Manufactured by:

• Sandoz Inc.
• Princeton, NJ

What should I know about storage and disposal of this medication?

• Store at 68° to 77°F (20° to 25°C).
• Keep clonazepam tablets and all medicines out of the reach of children.

• Dailymed label info on Clonazepam
• FDA Clonazepam

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